MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - SINGAPORE DTX SAFEDRAW KITS.GABARITH¿; COMPUTER, BLOOD-PRESSURE

Catalog Number	688420/D
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Fracture (1260); Unable to Obtain Readings (1516)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The complaint alleges that a patient had massively elevated blood pressure while lying for a long time (>300 mmhg systolic), anti hypertensive medication was immediately administered and a trip to the ct was needed to rule out the suspicion of a cerebral hemorrhage.When changing the blood pressure transmission to the transport monitor, the clinical team noticed that a contact was broken.The nursing staff could not identify the cause.
Additional Manufacturer Narrative
The suspect medical device was not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and three similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: DTX SAFEDRAW KITS.GABARITH¿
• Common Device Name: COMPUTER, BLOOD-PRESSURE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - SINGAPORE; 198 yishun ave7; singapore 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - SINGAPORE; 198 yishun ave7; singapore 76892 6; SN 768926
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21318386
• Report Number: 8020616-2025-00004
• Device Sequence Number: 8063035
• Product Code: DSK
• UDI-Device Identifier: 00884450654538
• UDI-Public: 884450654538
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 688420/D
• Device Lot Number: C2978868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown